This is an ancillary to the NIDDK-sponsored Hepatitis B Research Network (HBRN) Study Cohort Study NCT01263587. This study will examine the balance between immune regulatory and effector responses in hepatitis B-infected participants enrolled in the HBRN study (NCT01263587).

Aim 1: The clinical and virological status of chronic Hepatitis B (HBV) infection is defined by distinct patterns of immune effector and regulatory responses: The investigators propose that one or more immune regulatory are induced during chronic hepatitis B that define the extent of immune tolerance vs. activation with associated disease activity and viremia. Towards this end, the immune effector and regulatory responses relative to serum HBV DNA, alanine aminotransferase (ALT), Hepatitis B e antigen (HBeAg), Hepatitis B surface antigen (HBsAg) and liver histology will be examined in a cross-sectional manner in patients with chronic HBV and control groups.

The study population will be recruited from multi-site clinical centers in the United States and Canada including primary care hospitals and community centers that have enrolled into the HBRN cohort study (NCT01263587).

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Please refer to this study by its ClinicalTrials.gov identifier: NCT01298037

Locations

United States, California

California Pacific Medical Center

San Francisco, California, United States, 94107

University of California San Francisco Medical Center

San Francisco, California, United States, 94143

United States, Massachusetts

Massachusetts General Hospital

Boston, Massachusetts, United States, 02114

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States, 02115

United States, Minnesota

University of Minnesota

Plymouth, Minnesota, United States, 55446

Mayo Clinic Rochester

Rochester, Minnesota, United States, 55905

United States, North Carolina

University of North Carolina

Chapel Hill, North Carolina, United States, 27599

United States, Texas

University of Texas Southwestern

Dallas, Texas, United States, 75390

United States, Virginia

Virginia Commonwealth University

Richmond, Virginia, United States, 23298

United States, Washington

Virginia Mason Medical Center

Seattle, Washington, United States, 98101

Harborview Medical Center

Seattle, Washington, United States, 98104

Canada, Ontario

University of Toronto

Toronto, Ontario, Canada, ON M5G 1X8

Sponsors and Collaborators

University of Pittsburgh

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)